Cleared Traditional

COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE (K881284) - FDA 510(k) Clearance

Class I Physical Medicine device.

K881284 · Nathaniel Gould Diagnostics, Inc. · Physical Medicine device
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Jul 1988
Decision
118d
Days
Class 1
Risk

K881284 is an FDA 510(k) clearance for the COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE. Classified as System, Pressure Measurement, Intermittent (product code JFC), Class I - General Controls.

Submitted by Nathaniel Gould Diagnostics, Inc. (Wallingford, US). The FDA issued a Cleared decision on July 21, 1988 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1600 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Nathaniel Gould Diagnostics, Inc. devices

Submission Details

510(k) Number K881284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1988
Decision Date July 21, 1988
Days to Decision 118 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JFC System, Pressure Measurement, Intermittent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1600
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.